Design and conduct of clinical trials in patients with osteoarthritis of the hand: recommendations from a task force of the Osteoarthritis Research Society International

Population-based normative values for the Western Ontario and McMaster (WOMAC®) osteoarthritis index and the Australian/Canadian (AUSCAN) hand osteoarthritis index functional subscales

“…The WOMAC Ò Index is currently available in 83 alternate language translations (Bellamy 2008b), while the AUSCAN Index is available in 32 alternate languages (Bellamy 2006). Both the WOMAC Ò and AUSCAN Indices are recognised in Osteoarthritis Research Society International (OARSI) Guidelines for clinical trials (OARS 1996;Maheu et al 2006), and the WOMAC Ò Index is also recognised in United States Food and Drugs Administration (FDA) (US FDA 1999), European Medicines Agency (EMEA) (EMEA 1998), Outcome Measures in Rheumatology Clinical Trials (OMERACT) (Bellamy et al 1997) and Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT) Guidelines (Turk et al 2003;Dworkin et al 2005). The use of valid, reliable and responsive measures is a key element of FDA PRO Guidelines (US FDA 2006).…”

Toward a Standardized Reporting of Outcomes in Hand Osteoarthritis: Developing a Common Metric of Outcome Measures Commonly Used to Assess Functioning

“…The impact of hand OA on people's functioning over the course of their life are comparable to people with rheumatoid arthritis (6), which is concerning considering that OA is the most prevalent rheumatic disease (7). Given the importance of func-tioning in hand OA, its assessment has been included in standards for quality of care (8,9) and recommendations for clinical trials (10,11).…”

Electronic Data Capture (EDC) using cellular technology: Implications for clinical trials and practice, and preliminary experience with the m-Womac® Index in hip and knee OA patients

“…In the last 25 years, there has been steady progress in the development of measurement techniques for osteoarthritis (OA), and agreement on core set measures (Bellamy et al, 1997a;OARSI Task Force, 1996;Maheu et al, 2006). More recently, attention has focussed on the elaboration of definitions of response (Dougados et al, 2000;Ehrich et al, 2000;Pham et al, 2004;Bellamy et al, 2005a;Tubach et al, 2005a;Bellamy et al, 2005b;Bellamy et al, 2004a;Bellamy and Wilson, 2007a;Kvien et al, 2007) and state-attainment (Kvien et al 2007., Tubach et al, 2005bBellamy et al, 2004b; for hip and knee OA patients.…”

“…More recently, attention has focussed on the elaboration of definitions of response (Dougados et al, 2000;Ehrich et al, 2000;Pham et al, 2004;Bellamy et al, 2005a;Tubach et al, 2005a;Bellamy et al, 2005b;Bellamy et al, 2004a;Bellamy and Wilson, 2007a;Kvien et al, 2007) and state-attainment (Kvien et al 2007., Tubach et al, 2005bBellamy et al, 2004b; for hip and knee OA patients. The concepts of standardised measurement in OA using valid reliable and responsive instruments has been recognised in US Food and Drugs Administration (FDA) (US FDA,1999), European Agency for the Evaluation of Medicinal Products (EMEA, 1998), OARSI (OARSI Task Force, 1996;Maheu et al, 2006), IMMPACT (Turk et al, 2003;Dworkin et al, 2005) and OMERACT (Bellamy et al, 1997a) Guidelines. These guidelines principally concern research-based applications.…”